Gradual vs. Abrupt Cessation Treatment for Smoking

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Smoking Cessation
Interventions:	Behavioral: Reduction Phone Counseling; Behavioral: Abrupt Phone Counseling; Behavioral: Minimal Abrupt Phone Counseling; Drug: Pre-Quit Nicotine Lozenges; Drug: Post-Quit Nicotine Lozenges

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited using advertisements targeting smokers who wanted to quit smoking gradually. Advertisements were placed in newspapers in two cities in South Carolina and one city in New Mexico.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled sample size of 750; 4 were excluded because found to be ineligible after enrollment.

Reporting Groups

	Description
Gradual Reduction	Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
Abrupt Cessation	Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
Minimal Intervention	Minimal intervention to mimic intervention at a primary care office

Participant Flow for 2 periods

Period 1:   Set Quit Date

	Gradual Reduction	Abrupt Cessation	Minimal Intervention
STARTED	297	299	150
COMPLETED	290	286	145
NOT COMPLETED	7	13	5
Lost to Follow-up	7	13	5

Period 2:   6 Month Follow-up

	Gradual Reduction	Abrupt Cessation	Minimal Intervention
STARTED	290	286	145
COMPLETED	227	237	118
NOT COMPLETED	63	49	27
Lost to Follow-up	63	49	27

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Gradual Reduction	Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
Abrupt Cessation	Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
Minimal Intervention	Minimal intervention to mimic intervention at a primary care office
Total	Total of all reporting groups

Baseline Measures

	Gradual Reduction	Abrupt Cessation	Minimal Intervention	Total
Overall Participants Analyzed; [Units: Participants]	297	299	150	746
Age; [Units: Participants]
<=18 years	0	0	0	0
Between 18 and 65 years	273	276	139	688
>=65 years	24	23	11	58
Age; [Units: Years]; Mean (Standard Deviation)	48 (13)	48 (12)	47 (13)	48 (13)
Gender; [Units: Participants]
Female	159	165	80	404
Male	138	134	70	342
Region of Enrollment; [Units: Participants]
United States	297	299	150	746

  Outcome Measures

1. Primary:

Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement [ Time Frame: 6 months ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our projected incidence of abstinence was higher than what was actually observed, leading to lower statistical power than expected.

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  

Name/Title: Dr. John Hughes
Organization: University of Vermont
phone: 802-656-9610
e-mail: John.Hughes@uvm.edu

Publications of Results:

Hughes JR, Solomon LJ, Livingston AE, Callas PW, Peters EN. A randomized, controlled trial of NRT-aided gradual vs. abrupt cessation in smokers actively trying to quit. Drug Alcohol Depend. 2010 Sep 1;111(1-2):105-13. doi: 10.1016/j.drugalcdep.2010.04.007. Epub 2010 May 26.

Responsible Party:	John Hughes, University of Vermont
ClinicalTrials.gov Identifier:	NCT00297492 History of Changes
Other Study ID Numbers:	R01DA011557-07 ( U.S. NIH Grant/Contract ); R01DA011557-07 ( U.S. NIH Grant/Contract )
First Submitted:	February 24, 2006
First Posted:	February 28, 2006
Results First Submitted:	May 31, 2012
Results First Posted:	September 5, 2012
Last Update Posted:	September 20, 2013